Casey Sciano, Enterprise Executive, TEKLYNX Americas04.26.24
Many companies have a label design and approval process that is informal, manual, and prone to mistakes. According to the United States Food and Drug Administration (FDA), 40% of recalls are due to labeling errors. Labeling mistakes are no small issue.
So, how can you reduce the risk of labeling errors to near zero? With an automated label audit trail. A label audit trail is a reliable, consistent way of documenting changes made to label designs to reduce the risk of labeling errors and help pinpoint the cause of error.
A label audit trail explained
An audit trail is simply a record of changes made to an entity. When it comes to labeling, a label audit trail is an accurate and detailed record of changes made to labels and actions taken with those labels. A detailed label audit trail contains data such as:
The benefits of a label audit trail
Having a detailed label audit trail has many benefits, from improving internal processes to minimizing damage in a labeling-related recall. Here are three of the most important benefits:
Industries that require label audit trails
Maintaining a label audit trail is required in certain industries. The FDA 21 Code of Federal Regulations (CFR) Part 11 labeling regulation requires medical device manufacturers and pharmaceutical companies to maintain records of their labeling process. Electronic signatures, a feature of labeling audit trail software, are required for accountability and security.
For the food and beverage industry, while label audit trails are not required by any federal regulation, labeling accuracy is crucial. Regulations such as the Food Safety Modernization Act (FSMA), Food Allergen Labeling and Consumer Protection Act (FALCPA), and Produce Traceability Initiative (PTI) are in place to promote the safety of the food supply chain. Food and beverage companies can maximize their protection against labeling errors by taking advantage of a label audit trail.
Other industries, such as chemical, aerospace and defense, and cannabis, have similar safety labeling requirements. While a label audit trail is not required, the benefits of having one in place are highly valued by companies in these industries.
Setting up a label audit trail
The last step in the process is to set up a label audit trail and protect your company from labeling errors. Below are some recommendations.
So, how can you reduce the risk of labeling errors to near zero? With an automated label audit trail. A label audit trail is a reliable, consistent way of documenting changes made to label designs to reduce the risk of labeling errors and help pinpoint the cause of error.
A label audit trail explained
An audit trail is simply a record of changes made to an entity. When it comes to labeling, a label audit trail is an accurate and detailed record of changes made to labels and actions taken with those labels. A detailed label audit trail contains data such as:
- Who requested a new label design, when, and why
- Who designed the label
- Who requested edits, edited the label, and why
- Who approved the label
- Who printed the label, when it was printed, to which printer it was printed to, quantity of the labels, and the variable data printed on the labels.
The benefits of a label audit trail
Having a detailed label audit trail has many benefits, from improving internal processes to minimizing damage in a labeling-related recall. Here are three of the most important benefits:
- Enforced label change and approval process: A prerequisite to implementing a label audit trail is to define an electronic label approval process. This typically involves three steps: design, approval, and print, but it can be customized for your company’s needs. A defined and enforced label approval process ensures the right people are involved in the process at the right time. It also ensures that unapproved labels cannot be printed and enter the production environment.
- Automatic label traceability: A label audit trail is an unbiased system that tracks exactly what happens with your labels automatically. You should never have to rely on memory, subjective interpretation of notes, or scribbled handwriting. With a label audit trail, the system is responsible for reporting rather than humans.
- Label error detection and tracing: If a labeling error occurs, a label audit trail makes it extremely easy to access the entire history of the affected label. Once the error is identified, it can be remedied. You’ll know exactly how many labels were affected and need to be pulled out of production for relabeling.
Industries that require label audit trails
Maintaining a label audit trail is required in certain industries. The FDA 21 Code of Federal Regulations (CFR) Part 11 labeling regulation requires medical device manufacturers and pharmaceutical companies to maintain records of their labeling process. Electronic signatures, a feature of labeling audit trail software, are required for accountability and security.
For the food and beverage industry, while label audit trails are not required by any federal regulation, labeling accuracy is crucial. Regulations such as the Food Safety Modernization Act (FSMA), Food Allergen Labeling and Consumer Protection Act (FALCPA), and Produce Traceability Initiative (PTI) are in place to promote the safety of the food supply chain. Food and beverage companies can maximize their protection against labeling errors by taking advantage of a label audit trail.
Other industries, such as chemical, aerospace and defense, and cannabis, have similar safety labeling requirements. While a label audit trail is not required, the benefits of having one in place are highly valued by companies in these industries.
Setting up a label audit trail
The last step in the process is to set up a label audit trail and protect your company from labeling errors. Below are some recommendations.
- Leverage label audit trail software: Label audit trail software is specifically designed to create an automated, searchable, accurate label history. Label security and traceability software meets these goals.
- Use off-the-shelf software: A useful label audit trail is electronic, searchable, and accurate. Achieve these goals with specialized off-the-shelf software, which is more cost effective and future-proof than developing custom software.